NCT00480662
Completed
Phase 3
A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone
ConditionsPaget's Disease of Bone
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Paget's Disease of Bone
- Sponsor
- Organon and Co
- Enrollment
- 60
- Primary Endpoint
- Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease
Exclusion Criteria
- •Patient cannot stand or sit upright for at least 30 minutes
- •Patient has difficulty swallowing or problems with digestive system
Outcomes
Primary Outcomes
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary Outcomes
- MK0217 will be safely tolerated
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